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SURESCAN™ SW030
Programmer software
Programming Guide
AZURE MRI™ SURESCAN™ / ASTRA MRI™
SURESCAN™ SW030
Programming Guide
A guide to programming the Azure™ MRI SureScan™ and Astra™ MRI SureScan™
pacemakers using the Medtronic SW030 application software on a Medtronic programmer
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic.
Third-party trademarks (“TM*”) belong to their respective owners. The following list includes
trademarks or registered trademarks of a Medtronic entity in the United States and/or in other
countries.
Astra™, Azure™, Capture Management™, Cardiac Compass™, CareAlert™,
CareLink Encore™, CareLink™, Conexus™, Flashback™, Marker Channel™,
Medtronic CareAlert™, Medtronic CareLink™, MVP™, OptiVol™, Paceart™, Quick Look™,
SessionSync™, SureScan™, TherapyGuide™
AZURE MRI™ SURESCAN™ / ASTRA MRI™ SURESCAN™
Medtronic SW030
Contents
1 Software overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.1 CE mark of conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.3 Software description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.4 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.5 Intended purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.6 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.7 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.8 Potential adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2 Patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.1 Conducting a patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.2 Starting a patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.3 Interrogating the device during a patient session . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.4 Responding to device status indicator warnings . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.5 Quick Look II screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.6 Programmer screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.7 Enabling emergency VVI pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.8 Patient information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.9 Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2.10 Using a checklist to complete tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
2.11 Printing reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2.12 Exporting data to the Paceart system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
2.13 Saving and retrieving device data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
2.14 Ending a patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
3 Diagnostic data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
3.1 Diagnostic data overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
3.2 CareAlert Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
3.3 Clinical diagnostic data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
3.4 Device and lead performance data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
4 System test and EP study features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
4.1 Overview of system test and EP study features . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
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6 Programming Guide
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1 Software overview
1.2 Introduction
This manual describes the Medtronic Model SW030 programmer software and explains how
to use a programmer to conduct a patient session.
Throughout this manual the word “device” refers to the implanted pacemaker. The names of
screen titles and interactive screen elements are shown in bold type. Navigation paths to
software screens or programmable parameters are shown with a “>” character between
steps in the path (for example, Data > Device/Lead Diagnostics > Lead Impedance
Trends > Open Data).
The software features described in this manual apply to the Azure XT DR MRI SureScan
devices. To determine which features are available for another model in the Azure MRI
SureScan or Astra MRI SureScan families, refer to the device reference manual. If this
manual is supplied in its printed form and any part of it is illegible, contact a Medtronic
representative to request a replacement manual.
Additional manuals and documents with information about the programmer and implanted
device:
MRI technical manual – This manual provides MRI-specific procedures and warnings and
precautions.
Reference manual – This manual contains information about device features. The
reference manual applies to multiple models of IPG devices.
Programmer reference manual – This manual contains information about the features of
the programmer. There are separate programmer reference manuals for the Medtronic
CareLink 2090 programmer and the Medtronic CareLink Encore 29901 programmer.
Device manual – This manual contains model-specific feature information, indications and
contraindications, warnings and precautions, instructions for implanting the device, quick
reference specifications, and parameter tables.
Explanation of symbols – This document defines the symbols that may appear on the
device package. Refer to the package label to see which symbols apply specifically to this
device.
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Medical Procedure and EMI Warnings and Precautions Manual for Health Care
Professionals – This manual provides warnings, precautions, and guidance for health care
professionals who perform medical therapies and diagnostic procedures on cardiac device
patients. The manual also provides patient education information related to sources of
electromagnetic interference (EMI) at home, at work, and in other environments.
Radio regulatory compliance information – This document provides compliance
information related to the radio components of the device.
1.6 Contraindications
No contraindications related to the use of this software are known; however,
contraindications related to the use of the implantable devices and programmers that are
compatible with this software can be found in the appropriate manual for the compatible
device.
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2 Patient session
Note: If you are using the Medtronic CareLink Programmer with Conexus telemetry, you
must use the programmer in the nonwireless telemetry mode.
For information about setting up the programmer for a patient session, using the
programming head, or compatible programming heads, refer to the programmer reference
manual.
The programmer interrogates the patient’s device at the start of a patient session. End the
previous session before starting a session with another patient.
You can expect reliable telemetry between the implanted device and the programmer in a
typical examination room or operating room.
Note: During an initial interrogation, only emergency programmer functions are available.
Caution: A programmer failure (for example, a faulty touch pen) could result in inappropriate
programming or the inability to terminate an action or activity in progress. In the event of a
programmer failure, immediately turn off the programmer power to deactivate telemetry and
terminate any programmer-controlled activity in progress.
Use the following steps to start a patient session:
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Note: The programming head contains a magnet that suspends tachyarrhythmia detection
and initiates magnet mode pacing until telemetry between the device and programmer is
established.
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After a device reset, a device status indicator is recorded. For a device reset that requires
attention, the device status indicator warning describes how the reset affected the device
data. Read the message accompanying the indicator and follow the screen instructions
carefully. If the message indicates that the reset affected device parameters, you must
reprogram the device to restore the previous settings.
If the programmer displays a device reset message for an implanted device, perform the
following steps:
1. Remove any sources of electromagnetic interference (EMI).
2. Notify a Medtronic representative.
3. Tap Clear in the window to clear the device status indicator.
A confirmation window appears indicating that all previously interrogated data in the
programmer will be cleared.
4. Tap Continue.
Note: If a device reset occurred while the MRI SureScan parameter was programmed
to On, the MRI SureScan window appears. Program the MRI SureScan parameter to
Off before continuing with the next step.
9. Verify that the device date and time are correct. If necessary, a Medtronic
representative can reprogram the date and time.
10. Check the Battery and Lead Measurements screen to verify that the battery voltage
is acceptable.
11. Conduct lead impedance and pacing threshold tests as desired.
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Note: The Quick Look II screen shows information collected since the last patient session
and stored in the device memory. Programming changes made during the current session
may also affect the Quick Look II observations.
You can update the Quick Look II data during a session by reinterrogating the device.
The Quick Look II screen is automatically displayed after the patient session is started. To
access the Quick Look II screen from another screen, tap Data > Quick Look II.
Available information:
To view relevant details about a section of the screen, tap the button.
Remaining Longevity – The Remaining Longevity estimate shows the estimated time
remaining until Recommended Replacement Time (RRT).
To access the Battery and Lead Measurements screen, tap the button next to the
Remaining Longevity field.
Lead status and trends – Information about lead status allows you to assess the
performance and integrity of leads and identify any unusual conditions. The “Last Measured”
column shows the most recently measured lead impedance for each lead. To see more
details, tap the button in the “Last Measured” column.
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The lead trend graphs show lead impedance, capture threshold, and sensing amplitude
measurements recorded over the last 12 months. To see more details, tap the button
beside any of the lead trend graphs.
The graph legends contain the last measured values. To see more details about these
values, tap the button.
Pacing and sensing information – This information can help to assess the patient’s AV
conduction status and evaluate the effectiveness of programmed device settings.
Notes:
• “MVP On” and “MVP Off” refer to the currently programmed pacing mode, not the usage
of MVP mode pacing since the last session. If the device was programmed to an MVP
mode during the reporting period, a high percentage of ventricular pacing may indicate
that the patient has heart block.
• The paced and sensed event counters do not count all events recorded by the device.
Some device features (for example, Ventricular Safety Pacing) affect the way events are
counted. Also, due to rounding, percentages may not add up to 100%.
Arrhythmia episode information – This section shows the number of treated and
monitored arrhythmia episodes that have occurred since the last patient session. To access
the Arrhythmia Episodes data screen, tap the button next to either the Treated or
Monitored field.
Cardiac Compass trend data – The Cardiac Compass Trends screen provides a picture of
the patient’s condition during the last 14 months. The trend information can help to assess
whether device therapies or antiarrhythmic drugs are effective. To access the Cardiac
Compass Trends screen, tap the button next to the Cardiac Compass field.
Rate Histograms data – The Rate Histograms screen provides information about heart
rates recorded between patient sessions. This data can help you to monitor a patient’s
condition and assess the effectiveness of therapies. To access the Rate Histograms screen,
tap the button next to the Rate Histograms field.
Observations – Observations are based on an analysis of programmed parameters and
data collected since the last session. Observations alert you to unexpected conditions
related to device and lead status, parameter settings, arrhythmia episodes, and clinical
status.
If you select one of the displayed observations, the button becomes active if more
information about the selected observation is available. You can use the button to look at
relevant details.
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You can view live waveform traces, freeze waveform traces, record live waveform traces to
the programmer strip chart recorder or Electronic Strip chart (eStrip) recorder, whichever is
available. You can then recall any saved waveform strips before you end a patient session.
In addition to waveform traces, the Live Rhythm Monitor window shows the following
information:
• If telemetry has been established with the device, heart rate and interval are displayed.
• If parameters are programmed, an annotation appears above the waveform trace
showing the point at which programming occurred.
The Live Rhythm Monitor window appears in partial-screen view by default. To expand this
window to full-screen view, tap the small square button in the upper-right corner of the
window or tap the Adjust… button. The display of waveform traces in the Live Rhythm
Monitor window varies depending on which sources you select during data collection setup
and how you arrange traces in the full-screen view.
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Button Description
Increase the size of the waveform trace.
Identifies a waveform trace selected for printing. Tap the button to clear the
selection and choose a different trace.
Select the waveform trace for printing. You can select up to 2 waveform traces for
printing.
3. Adjust the appearance of all waveform traces by using the controls in the Adjust…
window.
Optional adjustment Steps
Truncate the tops and bottoms of waveform Tap Clipping.
traces at a 22 mm boundary.
Change the bandwidth of waveforms to im- Tap ECG Filter and select the check box to
prove the clarity of the displayed ECG in the set the bandwidth to 0.5 to 40 Hz, or clear
presence of interference. the check box to set the bandwidth to 0.05 to
100 Hz.
Display pacing artifacts superimposed over Tap Show Artifacts.
waveform traces.
Control how quickly the waveform is drawn Tap Sweep Speed and select a speed (12.5,
across the display. 25, 50, or 100 mm/s).
Selecting a fast Sweep Speed produces
a wide waveform. Selecting a slow Sweep
Speed produces a narrow waveform.
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4. Tap OK.
The Adjust… window closes and the Live Rhythm Monitor window returns to its
previous size.
Notes:
• Any interruption in telemetry with the device may result in missing marker annotations
and symbols on the waveform trace display.
• The device stops transmitting marker data when you lift the programming head, unless
the Holter telemetry feature is programmed to On. If Holter telemetry is programmed to
On, the device transmits Marker Channel data and supplementary marker data
regardless of the position of the programming head.
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After a patient session is started, the navigation icons are available on all but the Emergency
or Live Rhythm Monitor Adjust… windows.
Table 1. Navigation icons
Opens the Checklist screen for simplified navigation through a set of follow-up tasks.
Displays the Parameters screen for viewing and programming device parameters.
Displays options for adjusting preferences, viewing parameter changes made during
the session, saving data, and ending the session.
Note: MRI SureScan feature operation is disabled when emergency VVI pacing is
programmed.
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1. During a patient session, verify that telemetry is established between the device and
the programmer.
2. Tap the on-screen Emergency button.
Emergency VVI pacing is enabled, and the programmer displays the Emergency
screen.
Note: You can also enable emergency VVI pacing by pressing the red mechanical
emergency VVI button on the programmer.
To terminate emergency VVI pacing, you must reprogram pacing parameters from the
Parameters screen.
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Note: The Patient Information screen should not be used in the place of the patient’s
medical chart. The Patient Information screen of the programmer software application is
provided as an informational tool for the end user. The user is responsible for accurate input
of patient information into the software. Medtronic makes no representation as to the
accuracy or completeness of the patient information that end users enter into the Patient
Information screen. MEDTRONIC SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT,
INCIDENTAL, OR CONSEQUENTIAL DAMAGES TO ANY THIRD PARTY WHICH RESULT
FROM THE USE OF THE PATIENT INFORMATION SUPPLIED BY END USERS TO THE
SOFTWARE.
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Field Description
History… Enter the patient’s clinical conditions. This information is made
available to the TherapyGuide feature.
Note: Entering this information from either the Patient Information
screen or the TherapyGuide screen updates the information on
both screens.
EF, on Select the ejection fraction from a table of values and select the
measurement date.
Physi- Select the physician’s name, phone number, and hospital from a list.
cian/Phone/Hospital To add physician information to the list, tap Modify List… and add
the information.
Last Update Displays the last date that changes made to patient information were
programmed into memory. This field is not selectable.
3. Tap PROGRAM.
2.8.2 Entering and viewing information about the MRI SureScan system and
other implanted hardware
Enter information about the leads and other implanted hardware, such as abandoned
devices and leads, lead extenders, or lead adaptors into the MRI SureScan System/Other
Hardware screen.
1. Tap Patient > Patient Information > MRI SureScan System/Other Hardware….
The MRI SureScan System/Other Hardware screen is displayed.
2. Tap each text field to enter or change its content:
Field Description
MR Conditional De- Displays the MR conditional status of the implanted device. This
vice Implanted field is not selectable.
MR Conditional Lead Specify whether Lead 1 is MR conditional by selecting Yes, No, or
1 Implanted Unknown.
Note: Selecting this parameter value from either the Patient Infor-
mation screen or the MRI SureScan System/Other Hardware screen
sets the parameters pending on both screens.
Lead 1 Model Enter the model information for Lead 1.
MR Conditional Lead Specify whether Lead 2 is MR conditional by selecting Yes, No, or
2 Implanted Unknown.
Note: Selecting this parameter value from either the Patient Infor-
mation screen or the MRI SureScan System/Other Hardware screen
sets the parameters pending on both screens.
Lead 2 Model Enter the model information for Lead 2.
Other Devices Enter information to specify any other in-use or abandoned devices.
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Field Description
Other Leads Enter information to specify any other in-use or abandoned leads.
Lead Exten- Enter information to specify any in-use or abandoned lead extenders
ders/Adaptors or adaptors.
Other Hardware Enter up to 50 characters of notes about other implanted hardware.
Notes Note: The presence of other hardware in the patient may have an
impact on whether the patient can have an MRI scan.
Last Update Displays the last date that changes made to patient information were
programmed into memory. This field is not selectable.
3. Tap OK.
The Patient Information screen is displayed.
4. Tap PROGRAM.
2.9 Parameters
Parameters are settings that control device functions and data collection. You view and
program parameters from the Parameters screen.
All device parameters that you can view and program appear as active fields. Some active
fields pertain to only 1 parameter, while other fields provide access to groups of parameters.
If a parameter cannot be programmed, no active field appears next to its name. All
permanent parameter changes can be programmed from the Parameters screen.
After you select new values for parameters, the new values are designated as pending
values. A field containing a pending value has a dashed rectangle as its border. Values
remain pending until you program them to device memory.
Parameter sets
Parameter sets are collections of parameter values that have been stored for quick retrieval.
They include the following types:
Medtronic Nominals – Parameter values suggested for the device by Medtronic. The
Medtronic Nominals cannot be customized or deleted.
Initial Interrogation Values – The permanently programmed parameter values as
determined by the first interrogation of the device during the patient session. The Initial
Interrogation Values cannot be customized or deleted.
Custom sets of values – Sets of parameter values that you create for a particular clinical
situation. For example, you may want to save a set of parameter values for an initial implant
setting, for a specific disease state, or for situations in which you need to repeatedly program
a particular set of parameters. The set of parameter values that you save can include both
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programmed and pending values. To delete a custom parameter set, use the Delete button
in the Get Parameter Set window.
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The programmer may display a message button next to the PROGRAM button that, when
tapped, provides access to additional information about the pending parameters. The
message button has one of the symbols described in the following table. When the message
button is tapped, the programmer opens a second window displaying one or more
messages. If there are multiple messages regarding the pending parameter values, the most
significant message determines which symbol appears on the button.
Table 3. Symbols that appear on the message button
Symbol Explanation
Interlock – Indicates that a parameter interlock exists. Programming is restricted until
you resolve the conflict. Tap this button for a message that describes the conflict.
Warning – Indicates that there is a warning associated with programming one or more
of the pending parameter values. Tap this button to view the warning message and
recommendations.
Informational – Indicates that there is an informational message regarding one or
more of the parameter values. Tap this button to view the message.
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Caution: The TherapyGuide feature does not replace a physician’s expert judgment. The
physician’s knowledge of the patient’s medical condition takes precedence over the set of
inputs presented to the TherapyGuide feature. The physician is free to accept, reject, or
modify any of the suggested parameter values.
When retrieved, suggested parameter values that are different than the programmed values
appear as pending values on the Parameters screen. The suggested parameter values are
stored in device memory only after you tap PROGRAM on the Parameters screen.
The clinical conditions can be entered in the TherapyGuide window or on the Patient
Information screen. If the clinical conditions were previously entered using the Patient
Information screen at implant or during a follow-up visit, they are displayed in the
TherapyGuide window.
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5. Tap PROGRAM to program the pending parameter values and clinical conditions to
device memory.
Notes:
• Data collection is automatic and cannot be turned off.
• The signal displayed on the Live Rhythm Monitor for EGM1, EGM2, and EGM3 sources
is controlled by the EGM Source and EGM Range parameters on this Data Collection
Setup screen.
• Pre-arrhythmia EGM storage works by keeping the EGM circuitry enabled at all times,
and therefore it reduces device longevity. If you select On − 1 month or On − 3 months,
Pre-arrhythmia EGM storage is automatically turned off after the time period expires.
Refer to the reference manual for the implanted device for more information about the
operation of Pre-arrhythmia EGM storage.
1. Tap Params > Data Collection Setup….
2. Set your preferences using the following fields and controls:
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Field Description
EGM Source For each EGM channel, define the source electrodes between which
the device records EGM signals.
Note: The cardiac interval measurements of the device are always
based on the signals sensed through the programmed sensing polarity
(not the stored diagnostic EGM). Therefore, your selection of EGM
sources does not affect bradycardia pacing or tachyarrhythmia detec-
tion.
EGM Range For each EGM channel, select a range. The EGM range setting affects
the resolution of the EGM signal; the lower the setting, the higher the
resolution. If the EGM signal is illegible or clipped, consider changing
the range selection.
Monitored Select a set of 2 sources to be used for monitored episode record
storage.
Pre-arrhythmia Indicate whether you want to store EGM data collected prior to an
EGM episode.
AT/AF and OptiVol Select the thresholds for AT/AF Daily Burden, Avg. V. Rate During
Settings… AT/AF, and OptiVol Threshold that will trigger Quick Look II Observa-
tions.
Note: If these observations are available for the implanted device, the
AT/AF and OptiVol Settings… field will not appear on the screen if
Wireless Telemetry with Monitor is programmed to On.
Device Select the appropriate Time Zone offset from Coordinated Universal
Date/Time… > Time (UTC) to adjust the device time.
Time Zone
Holter Telemetry Select a duration for the Holter telemetry feature to operate, or disable
Holter telemetry. When Holter telemetry is enabled, the device continu-
ously transmits EGM and Marker Channel data for the selected duration
regardless of the presence of the programming head.
Wireless Teleme- Turn the Wireless Telemetry with Monitor feature on or off.
try with Monitor Note: Wireless telemetry and Medtronic CareAlert Monitoring (if avail-
able) can only be used when Wireless Telemetry with Monitor is
programmed to On.
3. Tap OK.
The Data Collection Setup window closes and new values are displayed as pending
values.
4. Tap PROGRAM.
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Once you have completed the last task on the Task list, the button and the Go To Task
button become inactive. However, if you select a task in the list, both buttons become active
again and you can use them to move among the task screens.
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Note: The Medtronic Standard Followup Checklist and the Medtronic Standard Implant
Checklist cannot be edited or deleted.
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The selected preferences are stored and the Preferences window closes. The Initial
Interrogation Report prints automatically after interrogation.
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Note: The Session Summary is always included in the Final Report and cannot be
deselected.
1. Before ending a patient session, tap Reports > Preferences… > Final Report.
2. Select the reports to include in the Final Report.
3. If this is the first time you are establishing Final Report preferences, select All Settings
in the Parameters section.
4. Select OK.
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Note: You can also save reports and frozen waveform strips as PDF files by checking the
Save to PDF File option when printing.
The Medtronic CareLink 2090 programmer has a disk drive for 90 mm (3.5 inch) disks plus
a USB port for USB flash drives, and the Medtronic CareLink Encore 29901 programmer has
a USB port only. If your programmer has a USB port only, please disregard the information
about using a disk drive.
Any programmer equipped with a disk drive can read device data from or write device data
to a disk. However, if a USB flash drive is inserted into the programmer, it overrides the disk
drive for saving and retrieving device data. Disks may be used only when no USB flash drive
is inserted.
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Interrogate the device before saving data to a USB flash drive or a disk because the
programmer saves only the data it has interrogated. If the Interrogate How Much? window
is displayed, select All to save a record of all the information from the device. If an issue
needs to be investigated, selecting the All option provides more data for analysis.
During the save operation, the Emergency button remains displayed, and the Emergency
function is available. If an error occurs during a save operation, there may be a delay in
initiating the Emergency screen. Do not save to media during EP studies or when it is
possible that the Emergency function will be needed immediately. If the Emergency function
is used during a save operation, the device aborts the save operation.
Do not insert or remove a USB flash drive during the following operations:
• programming a device
• performing a Save To Media operation
• performing a Read From Media operation
• saving a report or a frozen waveform strip as a PDF file
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4. Tap Save.
If you are saving to a USB flash drive, a slight delay may occur while the USB flash drive
is authorized. The USB indicator on the task bar turns green to indicate that the USB
flash drive is available for use and the disk icon becomes unavailable.
While a Save To Media action is in progress, the progress indicator and the message “Save
To Media - In Progress” are displayed. Before removing a USB flash drive, wait a few seconds
after the progress indicator shows 100%.
Note: You cannot use the programmer to view reports that have been saved using the Save
to PDF File option. Reports that have been saved using the Save to PDF File option can
only be viewed on a computer equipped to display PDF files.
Warning: The Read From Media application is designed only for viewing saved data while
no patient session is in progress. You cannot program a device or deliver emergency
therapies from the Read From Media application.
Use the following steps to retrieve device data:
1. Insert a USB flash drive or a disk that contains information saved during a patient
session.
2. From the Select Model screen, select the product category from the View list.
3. Select the Read From Media version of the device application.
4. Tap Start.
A warning message is displayed informing you that programming a device and
emergency operations are not possible while you are in the Read From Media
application.
5. Tap OK.
6. Tap Open File….
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7. Select the data record that displays the desired device serial number, date, and time
and tap Open File.
The Read From Media application displays information from the saved session.
Note: Session data may be lost once a session has ended. Print session data or save the
session data to a USB flash drive or disk prior to ending the session to avoid permanent loss
of session data.
1. To review or print a list of changes made during this session, tap Session > Changes
This Session.
Note: Selecting Print… will allow you to print the list of changes made during this
session.
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3 Diagnostic data
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For each event, a log entry includes the date and time of the alert, a description of the event,
and the measurement or information that caused the event. Up to 15 events are stored.
• For devices with CareAlert Monitoring, use the following path to view alert events:
– Tap Data > CareAlert Events to view the most recent CareAlert Events.
– Tap Data > CareAlert Events > OptiVol Events to view the most recent OptiVol
Events.
• For devices without CareAlert Monitoring, tap Data > OptiVol Events to view the most
recent OptiVol Events.
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Note: For each episode type, when the log capacity is reached, data from the most
recent episodes overwrites the oldest episode data in the log.
3. To view detailed information about an episode, tap the episode in the episode log.
Details about the episode are displayed in the episode record area, in the lower portion
of the Arrhythmia Episodes screen.
4. Use the following options to control the data displayed in the episode record area:
Action Steps
Move to a specific area of the EGM view. Use the horizontal scroll bar to change the
displayed area.
Select a specific portion of an episode for Tap Plot. Use the arrow buttons to adjust the
which to view EGM data. location of the yellow box to select a portion
of the episode. Tap EGM to see the selected
data in the EGM format.
Change the format of the data for the selected Tap Plot, EGM, or Text to view the data in that
episode. format.
Maximize or minimize the plot, EGM, or text Use the or buttons to change the size
display. of the displayed episode in the window.
Switch the y-axis between interval and rate. Tap the white Interval/Rate box (in Plot view)
at the top of the y-axis.
Show or hide plot intervals as desired. Tap the Plot: check boxes in the legend.
Display a selected atrial interval. Tap EGM and maximize the display by tapping
the button. Tap the white Atrial Interval
box on the y-axis to change the atrial interval
shown on the display.
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This data may help to assess the patient’s heart rhythm and the performance of other
features such as Rate Response.
1. Tap Data > Clinical Diagnostics > Flashback Memory > Open Data or tap the
Flashback button on the record detail view for the most recent VT, Fast A&V, or AT/AF
episodes on the Arrhythmia Episodes screen.
2. Use the following options to control the data displayed:
Action Steps
Select the interval to view. Select an option under View Intervals Prior
to:.
Show or hide plot intervals as desired. Tap the Plot: check boxes.
Switch the y-axis between interval and rate. Tap the white Interval/Rate box at the top of
the y-axis.
Shrink or enlarge the region to display when Use the zoom region resize buttons to adjust
the view is maximized. the location of the yellow box to select a por-
tion of the interval. Tap to shrink the region
to display and tap to enlarge the region to
display. Tap to maximize the view of the
selected data in the yellow box.
Reposition the region to display when the view Use the arrow buttons to adjust the location
is maximized. of the yellow box to select a portion of the
interval. Tap to maximize the view of the
data in the yellow box.
Maximize or minimize the view of the selected Use the or buttons to change the size
region. of the displayed interval in the window.
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Action Steps
Move to a specific area of the Markers view. Use the horizontal scroll bar to change the
displayed area.
Select a portion of the plot that will be expand- Tap Plot and use the arrow buttons to adjust
ed when entering the Markers view. the location of the yellow Marker Channel box
to select a portion of the plot. Tap Markers to
see the selected data in the Markers view.
Change the format of the data for the selected Tap Plot, Markers, or Text to view the data in
episode. that format.
Maximize or minimize the plot, markers, or text Use the or buttons to change the size
display. of the displayed episode in the window.
Switch the y-axis between interval and rate. Tap the white Interval/Rate box (in Plot view)
at the top of the y-axis.
Show or hide plot intervals as desired. Tap the Plot: check boxes (in Plot view) in the
legend.
Display a selected atrial interval. Tap Markers and maximize the display by
tapping the button. Tap the white Atrial
Interval box on the y-axis to change the atrial
interval shown on the display.
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Warning: Replace the device immediately if the programmer displays an End of Service
(EOS) indicator. The device may lose the ability to pace, sense, and deliver therapy
adequately after the EOS indicator appears.
Note: If the programmer displays the Recommended Replacement Time (RRT) indicator,
contact your Medtronic representative and your patient to schedule a replacement
procedure.
1. Tap Data > Device/Lead Diagnostics > Battery and Lead Measurements > Open
Data.
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1. Tap Data > Device/Lead Diagnostics > Capture Threshold Trends > Open Data.
The Lead Trends screen is displayed.
2. Select the chamber to display.
3. Optionally, tap the button to view details of the last 15 days of threshold measurement
data.
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3. Tap OK.
Test preferences are saved and the Preferences screen closes.
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Caution: While the Underlying Rhythm Test is in progress, patients are not receiving pacing
support because the device is temporarily programmed to a nonpacing mode. Pacing is
inhibited as long as you press and hold the INHIBIT Press and Hold button. Carefully
consider the implications of performing this test on pacemaker-dependent patients.
Considerations for performing an underlying rhythm test:
• For all patients, consider lowering the programmed Lower Rate and ensuring that the
patient is at this rate before inhibiting pacing. These actions may help avoid sudden
changes in the ventricular rate support.
• Tachyarrhythmia detection is suspended during the Underlying Rhythm Test
Use the following steps to perform an underlying rhythm test:
1. Tap Tests > Underlying Rhythm.
2. Verify the Permanent Values for Mode and Lower Rate.
• Consider lowering the programmed lower rate to help avoid sudden changes in
ventricular rate support.
• Tap Params > Lower Rate and select an appropriate rate. Tap PROGRAM to
program any pending changes. The device will pace at the lower rate shown on the
Parameters screen.
• Tap Tests > Underlying Rhythm to return to the Tests - Underlying Rhythm
screen.
3. Press and hold INHIBIT Press and Hold.
4. Observe the display of the heart’s intrinsic rhythm.
Note: Pacing is inhibited until this button is released.
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and pulse width settings to ensure capture while minimizing output to maximize battery
longevity.
Considerations for measuring pacing thresholds:
• The selectable and default values provided by the Pacing Threshold Test depend on the
programmed values for bradycardia pacing therapy.
• After performing a Pacing Threshold Test, make sure that the permanently programmed
pulse width and amplitude parameters provide an adequate safety margin above the
pacing threshold.
• Tachyarrhythmia detection is suspended during the Pacing Threshold Test.
1. Tap Tests > Pacing Threshold.
2. Review the displayed values and consider the following options:
Optional task Steps
Change the values for Test Type, Chamber, Tap the field next to the parameter you wish to
or Decrement after. change and select the desired value for that
parameter.
Change the Test Value for Pace Polarity, Tap the field next to the parameter you wish to
Mode, Lower Rate, AV Delay, Amplitude, change and select the desired value for that
or Pulse Width. parameter.
Change the values for V. Pace Blanking, A. Tap Additional Settings… and then tap the
Pace Blanking, or PVARP. field next to the parameter you wish to change.
Select the desired value for that parameter.
3. Initiate the Pacing Threshold Test. Press and hold TEST Press and Hold.
4. Observe the Live Rhythm Monitor for loss of capture.
5. When capture is lost, immediately release TEST Press and Hold.
The device resumes its original pacing values and displays the Test Results window.
6. Verify the detected pacing threshold at which loss of capture occurred.
Note: If necessary, change the value for the detected pacing threshold by tapping that
value in the Threshold column on the Test Results window.
7. If desired, use the following options to view or change data in the Test Results window:
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8. When you have finished viewing or changing data on the Test Results window, tap
Close to return to the Pacing Threshold Test screen.
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Caution: Use caution when selecting temporary pacing settings for pacemaker-dependent
patients. These patients may not receive adequate pacing support while amplitude
measurements are being obtained.
The Sensing Test allows you to temporarily program pacing parameters to increase the
likelihood that sensed events will occur. Sensing amplitude measurements taken during a
Sensing Test may include events that are atypical or a result of oversensing (for example,
PVCs or far-field R-waves). These events are excluded from the daily automatic sensing
amplitude measurements the device collects and reports in the sensing amplitude trends.
Because of this difference in measurement operations, Sensing Test results may differ from
those reported in the sensing amplitude trend data.
Considerations for performing a Sensing Test
• During a Sensing Test, reduce the pacing rate gradually to minimize patient symptoms
associated with abrupt changes in heart rate.
• The Sensing Test ends automatically after a few seconds and restores the programmed
settings if no intrinsic events occur and no changes are made to the pacing rate.
• Do not adjust the values for A. Sensitivity and RV Sensitivity based on the results of the
Sensing Test. For more information, refer to the reference manual.
• Tachyarrhythmia detection is suspended during the Sensing Test.
Use the following steps to perform a sensing test:
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2. Verify the programmed Test Value parameters for Mode and AV Delay or accept the
values displayed.
Note: The pacing modes available under Test Value depend on the programmed
pacing mode.
The sensing test automatically stops when it is complete. When the test is complete, the
measurement results are displayed on the test screen and the pacing settings return to the
programmed values.
To compare the Sensing Test measurements with the automatic daily sensing amplitude
measurements, tap the P/R Wave Amplitude Trends button.
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Note: At any time during a Magnet test, lifting the programming head from over the patient’s
pacemaker for at least 2 s restores operation of the pacemaker to its permanent status. This
action should be taken in the event of programmer malfunction, loss of power, or the absence
of an appropriate command confirmation.
1. Tap Tests > Magnet.
2. The Magnet Strip check box is selected by default. If you want the test to also
automatically record a strip showing non-magnet operation, select the Non-Magnet
Strip check box.
3. Select Strip Durations values for the automatically collected strips.
4. Tap START Test.
Note: If necessary, you can stop the Magnet test by tapping STOP Test.
5. Tap the Magnet Strip icon or the Non-Magnet Strip icon to view the collected strip in
the frozen strip viewer.
Warning: Monitor the patient carefully when using an EP study function. Have an external
defibrillator ready for use when inducing any tachyarrhythmia. An induced tachyarrhythmia
may degenerate to ventricular fibrillation.
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delivered with automatic resume disabled, tap Resume or remove the programming head
from the implanted device.
Aborting an induction or therapy – As a safety measure, the programmer displays an
ABORT button that may be selected to immediately abort any induction or tachyarrhythmia
therapy in progress. A burst induction may also be aborted by releasing the Press and Hold
button. When a manual therapy is delivered, the device automatically aborts any induction
or automatic therapy in progress.
Temporary parameter values – The EP study functions use test values that do not change
the programmed parameters of the device. The test values take effect when the induction or
therapy begins. After the induction or therapy, the device reverts to its programmed
parameter values for bradycardia pacing and tachyarrhythmia therapy.
Programming head buttons – The programming head buttons are disabled during the
following situations:
• The Program button on the programming head is disabled during EP study inductions
and manual therapies. Use the appropriate button on the programmer screen to deliver
an induction or manual therapy.
• The Interrogate button on the programming head is disabled during EP study inductions
only. Use the Interrogate button on the programmer screen to interrogate the device
while the EP study induction screen is active.
Warning: Monitor the patient carefully when using an EP study function. Have an external
defibrillator ready for use when inducing any tachyarrhythmia. An induced tachyarrhythmia
may degenerate to ventricular fibrillation.
Use the following steps to induce AT/AF with a 50 Hz burst:
1. Tap Tests > EP Study.
2. Tap 50 Hz Burst in the list of inductions and therapies.
3. Set up the test using the following options:
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4. Verify the displayed test values. If needed, select new test values by tapping the value
you wish to change.
Note: If you want to provide VOO Backup pacing during the pacing burst, select values
for VOO Backup.
5. Press and hold 50 Hz BURST Press and Hold. As long as you press and hold the
50 Hz BURST Press and Hold button on the programmer screen, the device
continues delivering the induction (up to a maximum of 10 s). Release the button to end
the induction.
Note: If necessary, tap ABORT to abort a therapy in progress.
Warning: Monitor the patient carefully when using an EP study function. Have an external
defibrillator ready for use when inducing any tachyarrhythmia. An induced tachyarrhythmia
may degenerate to ventricular fibrillation.
The pacing pulses are delivered at a uniform, selectable interval to the designated chamber.
You can also specify the amplitude and pulse width of the pulses.
If you perform an atrial Fixed Burst induction, you may choose to have the device deliver VVI
Backup pacing. However, VVI Backup pacing during an atrial Fixed Burst induction may be
inhibited by crosstalk if the test value for atrial Amplitude is greater than 6 V.
Use the following steps to induce AT or VT with a Fixed Burst induction:
1. Tap Tests > EP Study.
2. Tap Fixed Burst in the list of inductions and therapies.
3. If the Select Chamber window appears, tap Atrium or RV to select a chamber in which
to perform the test.
4. Set up the test using the following options:
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5. Verify the displayed test values. If needed, select new test values by tapping the value
you wish to change.
6. Press and hold Fixed BURST Press and Hold. Release the button to end the
induction.
Note: If necessary, tap ABORT to abort a therapy in progress.
Warning: Monitor the patient carefully when using an EP study function. Have an external
defibrillator ready for use when inducing any tachyarrhythmia. An induced tachyarrhythmia
may degenerate to ventricular fibrillation.
PES delivers a selectable number of pacing pulses at the S1S1 interval and then delivers up
to 3 asynchronous pacing pulses at S1S2, S2S3, and S3S4 intervals. You can specify the
chamber, amplitude, pulse width, and pacing intervals for the induction.
If you perform an atrial PES induction, you may choose to have the device deliver VVI Backup
pacing. However, VVI Backup pacing during an atrial PES induction may be inhibited by
crosstalk if the test value for atrial Amplitude is greater than 6 V.
Use the following steps to induce AT or VT with a PES:
1. Tap Tests > EP Study.
2. Tap PES in the list of inductions and therapies.
3. If the Chamber Selection window appears, tap Atrium or RV to select a chamber in
which to perform the test.
4. Set up the test using the following options:
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5. Verify the displayed test values. If needed, select new test values by tapping the value
you wish to change.
6. Tap DELIVER PES. Release the button to end the induction.
Note: If necessary, tap ABORT to abort a therapy in progress.
Warning: Monitor the patient carefully when delivering a manual therapy. Have an external
defibrillator nearby and ready for immediate use. Potentially harmful tachyarrhythmias may
occur during device testing.
During follow-up appointments, manual therapies may be helpful in assessing therapy
effectiveness and making any necessary adjustments as part of chronic care. The available
manual therapies include Atrial Burst+, Atrial Ramp, Ventricular Ramp, Ventricular Burst,
and Ventricular Ramp+ pacing therapies.
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therapy begins. After the induction or therapy, the device reverts to its programmed
parameter values for bradycardia pacing and tachyarrhythmia therapy.
Programming head buttons – The Program button on the programming head is disabled
during manual therapies. Tap the appropriate DELIVER button to deliver a manual therapy.
Telemetry – Ensure that there is a telemetry link between the device and the programmer
before performing a manual therapy. Successful interrogation or programming confirms
proper communication between the device and the programmer.
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length using the selected R-S1(%RR) value. The second pulse is delivered at an interval
determined using the selected S1S2(%RR) percentage. Any remaining pulses in the
sequence are delivered at the selected S2SN(%RR) percentage.
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Glossary
antitachycardia pacing (ATP) – therapies that deliver rapid sequences of pacing pulses to
terminate tachyarrhythmias.
AT/AF detection – feature that analyzes the atrial rate and its effect on the ventricular rhythm
to determine whether the patient is currently experiencing an atrial tachyarrhythmia.
Depending on programming, the device delivers a programmed sequence of atrial therapies
or continues monitoring without delivering therapy.
Burst+ pacing – antitachycardia pacing (ATP) therapy that delivers sequences of atrial
pacing pulses with an interval that is a programmable percentage of the tachycardia cycle
length, followed by up to 2 premature stimuli delivered at programmable intervals. With each
sequence of Burst+ pacing delivered, the device shortens the pacing interval by a
programmable interval.
Burst pacing – manual antitachycardia pacing (ATP) therapy that delivers ventricular
pacing pulses with an interval that is a programmable percentage of the tachycardia cycle
length.
Capture Management – feature that monitors pacing thresholds with daily pacing threshold
searches and, if programmed to do so, adjusts the pacing amplitudes toward a target
amplitude.
Cardiac Compass Trends – overview of the patient’s condition over the last 14 months with
graphs that display long-term clinical trends in heart rhythm, such as frequency of
arrhythmias, heart rates, and device therapies.
crosstalk – condition when pacing in one chamber is sensed as intrinsic activity in another
chamber.
Decision Channel annotations – annotations to stored and telemetered EGM that
document details about tachyarrhythmia detection operations.
device reset – automatic device operation to recover from a disruption in device memory
and control circuitry. Programmed parameters may be set to default reset values. This
operation triggers a device status indicator.
device status indicator – value recorded in device memory to signify a condition or
problem that may affect device operation and that requires attention.
electromagnetic interference (EMI) – energy transmitted from external sources by
radiation, conduction, or induction that can interfere with device operations, such as
sensing, or can potentially damage device circuitry.
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EOS (End of Service) – battery status indicator displayed by the programmer to indicate
that the device should be replaced immediately and that it may not operate per
specifications.
ERI (Elective Replacement Indicator) – battery status indicator for when replacement of
the device is recommended. Key device parameters are automatically switched. For
example, pacing mode switches to VVI and Lower Rate goes to 65 min–1.
event – a sensed or paced beat.
Flashback Memory – diagnostic feature that records the intervals that immediately
preceded tachyarrhythmia episodes or that preceded the last interrogation of the device and
plots the interval data over time.
Holter telemetry – telemetry feature that transmits EGM and Marker Channel data
continuously for a programmable number of hours, regardless of whether telemetry actually
exists between the device and programmer.
last session – refers to the last time the device was successfully interrogated before the
current interrogation. A session ends 8 hours after the last interrogation.
Marker Channel recording – a pacing system feature used to simplify ECG interpretation
by identifying pacing and/or sensing operations.
Mode Switch – feature that switches the device pacing mode from a dual chamber atrial
tracking mode to a nontracking mode during an atrial tachyarrhythmia. This feature prevents
rapid ventricular pacing that may result from tracking a high atrial rate and restores the
programmed pacing mode when the atrial tachyarrhythmia ends.
MR Conditional – an item that has been demonstrated to pose no known hazards in a
specified MR environment with specified conditions for use.
MRI SureScan – a feature that permits a mode of operation that allows a patient with a
SureScan system to be safely scanned by an MRI machine while the device continues to
provide appropriate pacing.
MVP (Managed Ventricular Pacing) – atrial-based pacing mode that is designed to switch
to a dual chamber pacing mode in the presence of AV block. The MVP feature is intended to
reduce unnecessary right ventricular pacing by promoting intrinsic conduction. The MVP
modes are AAIR<=>DDDR and AAI<=>DDD.
oversensing – inappropriate sensing of cardiac events or noncardiac signals. Examples
include far-field R-waves, T-waves, myopotentials, and electromagnetic interference.
pacing threshold – minimum pacing output that consistently captures the heart.
PVC (premature ventricular contraction) – a sensed ventricular event that directly follows
any other ventricular event with no atrial event between them.
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Quick Look II data – overview data summarizing the most important indicators of system
operation and the patient’s condition, including information about device and lead status,
pacing therapy, arrhythmia episodes, and system-defined observations.
Ramp+ pacing – manual antitachycardia pacing (ATP) therapy that delivers ventricular
pacing pulses at programmable intervals that are based on percentages of the tachycardia
cycle length.
Ramp pacing – antitachycardia pacing (ATP) therapy that delivers pacing pulses with
progressively shorter pacing intervals per pulse. Each sequence of Ramp pacing that is
delivered during a therapy includes an additional pacing pulse.
Rate Drop Response – feature that monitors the heart for a significant drop in rate and
responds by pacing the heart at an elevated rate for a programmed duration.
Rate Drop Response episodes data – feature that displays beat-to-beat data that is useful
in analyzing Rate Drop Response episodes and the events leading up to those episodes.
Rate Histograms – diagnostic feature that shows range distributions for a patient’s heart
rate.
Rate Response – feature that adjusts the cardiac pacing rate in response to changes in
sensed patient activity.
Remaining Longevity estimate – an estimate of remaining device longevity that is
displayed on the Quick Look II and Battery and Lead Measurements screens. On both
screens, this information includes a graphical display for easy reference and the estimated
number of years or months of remaining longevity. On the Battery and Lead Measurements
screen, the Minimum and Maximum number of years or months of remaining device
longevity are also provided.
Resume – programming command that reinstates automatic tachyarrhythmia detection.
RRT (Recommended Replacement Time) – battery status indicator displayed by the
programmer to indicate when replacement of the device is recommended.
sensed event – electrical activity across the sensing electrodes that exceeds the
programmed sensitivity threshold and is identified by the device as a cardiac event.
sensor rate – the pacing rate determined by the level of patient activity and the programmed
rate response parameters; this rate is adjusted between the Upper Sensor Rate and the
operating Lower Rate.
Suspend – programming command that temporarily deactivates the tachyarrhythmia
detection functions.
Ventricular Safety Pacing (VSP) – pacing therapy feature that prevents inappropriate
inhibition of ventricular pacing caused by crosstalk or ventricular oversensing.
66 Programming Guide
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